PMID- 33780150 OWN - NLM STAT- MEDLINE DCOM- 20211019 LR - 20211019 IS - 1522-726X (Electronic) IS - 1522-1946 (Linking) VI - 98 IP - 2 DP - 2021 Aug 1 TI - Comparison of the investigational device exemption and post-approval trials of the Melody transcatheter pulmonary valve. PG - E262-E274 LID - 10.1002/ccd.29657 [doi] AB - OBJECTIVE: We compared 5-year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post-approval study (PAS) and the investigational device exemption (IDE) trial. BACKGROUND: As a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a "real-world" environment. The 5-year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared. METHODS: The cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time-related outcomes and valve-related adverse events were compared between the two trials with Kaplan-Meier curves and log-rank testing. RESULTS: 167 patients (median age, 19 years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17 years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction (p = .61) or any reintervention (p = .74) over time did not differ between trials. Freedom from stent fracture (p = .003) and transcatheter reintervention (p = .010) were longer in PAS, whereas freedom from explant (p = .020) and TPV endocarditis (p = .007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients (p = .056); the incidence of any particular event was low in both. CONCLUSIONS: Hemodynamic and time-related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real-world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post-approval studies as part of the regulatory process for Class III medical devices. CI - (c) 2021 Wiley Periodicals LLC. FAU - Kreutzer, Jacqueline AU - Kreutzer J AD - Division of Cardiology, Department of Pediatrics, University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA. FAU - Armstrong, Aimee K AU - Armstrong AK AUID- ORCID: 0000-0002-4534-5075 AD - The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA. FAU - Rome, Jonathan J AU - Rome JJ AD - Division of Cardiology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA. FAU - Zellers, Thomas M AU - Zellers TM AD - Division of Cardiology, Department of Pediatrics, University of Texas Southwestern and the Heart Center at Children's Health, Dallas, Texas, USA. FAU - Balzer, David T AU - Balzer DT AD - Division of Pediatric Cardiology, Washington University School of Medicine/Saint Louis Children's Hospital, St. Louis, Missouri, USA. FAU - Zampi, Jeffrey D AU - Zampi JD AUID- ORCID: 0000-0002-5865-9591 AD - Division of Pediatric Cardiology, University of Michigan Medical School, Ann Arbor, Michigan, USA. FAU - Cabalka, Allison K AU - Cabalka AK AD - Division of Cardiology, Mayo Clinic, Rochester, Minnesota, USA. FAU - Javois, Alexander J AU - Javois AJ AD - Advocate Children's Hospital, Section of Pediatric Cardiology, Advocate Children's Hospital, University of Illinois Hospital, Chicago, Illinois, USA. FAU - Turner, Daniel R AU - Turner DR AD - Division of Cardiology, Carman and Ann Adams Department of Pediatrics, Children's Hospital of Michigan, Detroit, Michigan, USA. FAU - Gray, Robert G AU - Gray RG AUID- ORCID: 0000-0002-8913-0543 AD - Department of Pediatrics, Division of Pediatric Cardiology, University of Utah, Salt Lake City, Utah, USA. FAU - Moore, John W AU - Moore JW AUID- ORCID: 0000-0002-1079-1200 AD - Department of Pediatric Cardiology, Rady Children's Hospital, UC San Diego, San Diego, California, USA. FAU - Weng, Shicheng AU - Weng S AD - Department of Biostatistics, Medtronic, Framingham, Massachusetts, USA. FAU - Jones, Thomas K AU - Jones TK AUID- ORCID: 0000-0002-4038-1210 AD - Department of Cardiology, Seattle Children's Hospital, Seattle, Washington, USA. FAU - Khan, Danyal M AU - Khan DM AD - The Heart Program, Nicklaus Children's Hospital, Miami, Florida, USA. FAU - Vincent, Julie A AU - Vincent JA AD - Division of Pediatric Cardiology, Columbia University Medical Center, New York, New York, USA. FAU - Hellenbrand, William E AU - Hellenbrand WE AD - Department of Pediatrics (Cardiology), Yale University School of Medicine, New Haven, Connecticut, USA. FAU - Cheatham, John P AU - Cheatham JP AD - The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA. FAU - Bergersen, Lisa J AU - Bergersen LJ AD - Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts, USA. FAU - McElhinney, Doff B AU - McElhinney DB AD - Department of Cardiothoracic Surgery, Lucille Packard Children's Hospital, Stanford University School of Medicine, Palo Alto, California, USA. LA - eng GR - Medtronic/ PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20210329 PL - United States TA - Catheter Cardiovasc Interv JT - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions JID - 100884139 SB - IM MH - Adolescent MH - Adult MH - Cardiac Catheterization/adverse effects MH - *Heart Valve Prosthesis MH - *Heart Valve Prosthesis Implantation/adverse effects MH - Humans MH - Prosthesis Design MH - *Pulmonary Valve/diagnostic imaging/surgery MH - *Pulmonary Valve Insufficiency/surgery MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - pulmonary heart disease OT - tetralogy of Fallot OT - transcatheter pulmonary valve replacement EDAT- 2021/03/30 06:00 MHDA- 2021/10/21 06:00 CRDT- 2021/03/29 13:54 PHST- 2020/11/03 00:00 [revised] PHST- 2020/07/14 00:00 [received] PHST- 2021/03/14 00:00 [accepted] PHST- 2021/03/30 06:00 [pubmed] PHST- 2021/10/21 06:00 [medline] PHST- 2021/03/29 13:54 [entrez] AID - 10.1002/ccd.29657 [doi] PST - ppublish SO - Catheter Cardiovasc Interv. 2021 Aug 1;98(2):E262-E274. doi: 10.1002/ccd.29657. Epub 2021 Mar 29.